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Microstructure secured and self-verifying medicines

Final Report Summary - SAVEMED (Microstructure secured and self-verifying medicines)

Executive Summary:
Counterfeit medicines are a serious and fast expanding threat for the customer’s health and the pharmaceutical manufacturers business. The aim of this research collaboration was to add anti-counterfeiting and track & trace technology to the product level that goes beyond the state-of-the-art security approach on the packaging level.
The project SAVEmed brought a solution for the counterfeit and the illegal re-import problem in the medical product market, thereby ensuring product pedigree and defend illegal re-packing.
In SAVEmed project the direct marking of medical products with secure microstructures was realised by modifying the tools used to manufacture the products as well as the ones used for their packages on the micron– and sub-micron level. The project aim was to transfer diffractive gratings, random microstructures, micro-barcodes and contrast generating micro-prisms in steel tools. Moreover, algorithm enabling cross checking of the secure microstructures on the product (even through coatings) and on the package was developed to
ensure the highest level of security possible. In SAVEmed this direct product marking approach was realized for pharmaceutical tablets, injection moulded pharma caps and laminated sterile pouches.
Nevertheless the approach is applicable to nearly all other types of medical products.
The strategies of criminal organisations was analysed and the development was adapted to counteract these strategies. Key advantage of the implementation of secure microstructures directly in or on the medical product itself is that no chemical or biological additives and that no costly changes of production lines are needed. Thus no additional approvals from regulatory agencies are requested.
This project ensured a correct balance of market-pull and technological push by including major actors in anti-counterfeit technology research, 3 SMEs, 2 large industries and pre-assembled end-users External Advisory Board.
Project Context and Objectives:
please refer to attached document
Project Results:
please refer to attached document
Potential Impact:
please refer to attached document

Patents:
two beneficiaries have agreed to a joint patent application on some of the project aspects to be filed during August 2014
serial number: not yet available

Exploitable foreground:
Exploitable foreground information is confidential manufacturing know-how shared by some beneficiaries - security project conditions prevent further publication

List of Websites:
www.savemed.org
NANO4U: Stefan Klocke, Mozartstrasse 7, 76133 Karlsruhe, Germany
CSEM: Marc Schnieper, Section Head Integrated Sensing & Security, Tramstrasse 99, 4132 Muttenz, Switzerland
Heliotis: Patrick Lamblet,Längenbold 5, 6037 Root, Switzerland
Klocke: Magnus Zuther, Max-Becker-Straße 6, 76356 Weingarten, Germany
Steripack: Thomas Smith, Kilbeggan Rd, Clara, Co. Offaly, Irland
UNICRI: Marco Musumeci, Office D-1, Palais des Nations, Avenue de la Paix 8-14, 1211 Geneva 10, Switzerland
Kutterer and Mauer: Malgorzata Horst, Klaus Höfflin, Krolow 37, 68-212 Trzebiel, Poland
final1-wp9-d9-5-final-report.pdf

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